Surgery – Container for blood or body treating material – or means used... – Bag type
Reexamination Certificate
1998-01-22
2001-02-06
Polutta, Mark O. (Department: 3762)
Surgery
Container for blood or body treating material, or means used...
Bag type
C604S410000, C209S720000
Reexamination Certificate
active
06183460
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to a container for holding medical solutions, and more specifically to a container for holding medical solutions having one or more flaps hingedly connected and extending from an edge of a fluid-tight chamber.
BACKGROUND OF THE INVENTION
In the medical field, various containers have been used to hold medical solutions such as blood, hemoglobin solutions or other blood substitutes, chemotherapeutic solutions, and other intravenous drip solutions. Frequently, these containers are bags which are either molded or fabricated from flexible plastic so they include one or more expandable chambers for holding medical solution. Additionally, one or more spouts generally extend outward from the chambers for filling and/or draining the container. These spouts are closed to seal the chambers until they are ready to be emptied.
Labels are usually applied to the container for carrying information regarding the medical solution held by the container. For instance, the label may describe the chemical composition of the solution held in the container, it may provide information regarding the origin or use of the medical solution, and/or it may provide regulatory information concerning the medical solution. Various agencies, including regulatory agencies, and jurisdictions generally require certain information to be present on the label in a specific form. For instance, regulatory agencies typically require the information to be provided in one or more specific languages.
Conventional small-volume solution containers have labeling space for only a limited amount of information. As a result of this limitation, a single label fixed to the container and providing all the information required by multiple regulatory agencies cannot be made. Therefore, medical solution manufacturers and distributors must anticipate where solutions will be needed and label the containers appropriately. However, this creates additional inventory problems. Alternatively, the manufacturers and distributors can wait until an order is placed and then label the containers so they include the information in the appropriate form required by the agency or agencies regulating the destination jurisdiction. However, both of these alternatives create problems and add expense to the distribution process.
Further, when the medical solution requires refrigeration prior to labeling, condensate forms on the exterior of the container as it warms. This condensate hampers labeling because adhesives may not stick to the wetted container. In addition, inks may run and become illegible if they come in contact with the condensate.
An additional problem includes the use of overpouches in conjunction with the medical container. When packaging the medical solution containers for shipment, the containers are generally placed in an overpouch. An overpouch is used to protect the medical container during shipment and storage. The overpouch usually takes the form of a bag which can be sealed following insertion of the medical solution container. However, protecting medical containers with overpouches is expensive and inefficient.
When using an overpouch, the medical container must be physically placed into an additional element. Thus, the manufacturer must not only manufacture the medical container itself, but must also manufacture or stock the overpouch. This increases cost and assembly time. Additionally, the overpouch itself is not often made of a material which can be easily seen through for visual inspection of the medical container itself, the information on the label of the medical container or the contents of the medical container. It is very important that the contents of the medical solution be visible to those who work with the medical containers such that a quick and detailed inspection of the solution for particulate matter, precipitates, or other visualizable contaminants, along with the information on the labeling of the container, can be performed. Thus, the use of a separate overpouch has several drawbacks.
SUMMARY OF THE INVENTION
The present invention provides a container for holding medical solutions. The container comprises a fluid-tight chamber having opposing first and second edges and opposing first and second surfaces. At least one flap extends from an edge of the chamber and is hingedly connected to the chamber. The flaps have multiple uses: they can carry information regarding the medical solution within the container; they can be utilized as a protective covering for the container; and, they can be utilized in combination as information carriers and protective coverings.
In general, a first flap extends from a first edge of the chamber and a second flap extends from a second edge of the chamber. The flaps are then generally positioned overlying either the first or second surface of the chamber, depending on the configuration desired.
In one embodiment of the present invention the flaps are utilized as a protective covering. The first flap is positioned such that at least part of the first flap overlies the first surface of the chamber, and the second flap is positioned such that at least part of the second flap overlies the second surface of the chamber. Then, the first and second flaps are sealably connected to form an integrated overpouch. Several variations of the present invention may be noted, including: the provision wherein a single flap is utilized for the entire overpouch element, the provision wherein multiple flaps extend from opposing or adjacent edges of the chamber, and the provision wherein multiple flaps extend from the same edge of the chamber.
In another embodiment of the present invention, the flaps carry information regarding the medical solution held by the container. Providing flaps on a container which carry information increases the labeling area without having to increase the interior volume or the interior surface area. Further, the flaps may include pockets. Information regarding the medical solution held by the container is inserted into the pockets in the flaps. It is also possible to provide flaps carrying information in addition to the flaps that form the overpouch. Preferably, the medical solution container contains multiple flaps wherein the same container has integral information carrier flaps and protective covering flaps.
Briefly, another aspect of the present invention includes a method of making a bag having a chamber capable of defining a fluid-tight volume for holding medical solution and at least one flap. The flap is moveable with respect to the chamber between a deployed position in which the flap extends outward from the chamber, and a stowed position in which the flap at least partially overlies the chamber. The method comprises the steps of superimposing first and second weldable-flexible plastic materials, and welding the first and second materials together along lines forming side, top and bottom seals to form the chamber. The lines are so located as to provide an area extending outwardly from one of the seals thereby forming the flap. The flap is hinged to the chamber at the one seal so as to be swingable between the stowed and deployed positions.
Other features and advantages of the invention will be apparent from the following specification taken in conjunction with the following drawings.
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Anderson Keith
Smith Sidney T.
Zietlow Joan
Baxter International Inc.
Buonaiuto Mark J.
Cho David J.
Fuchs Joseph A.
Polutta Mark O.
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